Randomized Control Trial, Cryoablation as an Adjunct to Surgical Stabilization of Rib Fractures

Single Center, Randomized Control Trial of Cryoablation During Surgical Stabilization of Rib Fractures

To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of Surgical Stabilization of Rib Fractures (SSRF) without cryoablation

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Rib Fracture Multiple
• Intervention / Treatment: Device: Cryoablation of Intercostal Nerves; Procedure: Standard surgical treatment of patients with multiple rib fractures

Detailed Description

Locoregional pain control with cryoneurolysis of intercostal nerves has been employed as an adjunct for longer term pain control. Initially introduced in thoracic surgery, intercostal nerve cryoablation has demonstrated adequate pain control and substantial decrease in opioid consumption and hospital length of stay.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bradely W Thomas, MD; Phone Number: 704-355-3176; Email: Bradley.Thomas@wfusm.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Bradley W Thomas, MD; Phone Number: 704-355-3176; Email: Bradley.Thomas@wfusm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient is admitted to the trauma service.
• The patient has multiple displaced rib fractures (≥2 ribs), offered fixation, and consents to SSRF
• The patient is not being treated for chronic pain
• The patient is >18 years of age.
• Surgery anticipated <120 hours from injury

Exclusion Criteria:

• Age < 18 years or ≥ 80 years
• Flail chest: either radiographic or clinical. Radiographic flail chest is defined on CT chest as ≥ 2 ribs each fractured in ≥ 2 places. Clinical flail is defined as visualization of a segment of chest wall with paradoxical motion on physical exam.
• Moderate or severe traumatic brain injury (Intra-cranial hemorrhage visualized on CT head with GCS at the time of consideration for enrollment < 12)
• Prior or expected emergency exploratory laparotomy during this admission
• Prior or expected emergency thoracotomy during this admission
• Prior or expected emergency craniotomy during this admission
• Spinal cord injury
• Pelvic fracture that has required, or is expected to require, operative intervention during this admission
• The patient was unable to accomplish activities of daily living independently prior to injury (e.g., dressing, bathing, preparing meals)
• The patient is incarcerated
• The patient is known to be pregnant
• Unable to perform Video Assisted Thoracoscopy (VATS) at time of SSRF due to lung isolation or previous pathology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy plus CRYOABLATION; Adding Cryoablation of levels 3-8, in addition to patients that undergo SSRF for multiple rib fractures.	Device: Cryoablation of Intercostal Nerves; Using Atricure device, cryoice, intercostal nerves 3-8 will be ablated in the experimental arm. This is in addition to mechanical fixation of rib fractures and multimodal systemic therapy.
Active Comparator: Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy; Standard surgical treatment of patients with multiple rib fractures plus Multimodal Pain Therapy	Procedure: Standard surgical treatment of patients with multiple rib fractures; Standard surgical treatment of patients with multiple rib fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine Milligram Equivalents Use following Intervention	To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.	Baseline
Morphine Milligram Equivalents Use following Intervention	To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.	Day 1
Morphine Milligram Equivalents Use following Intervention	To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.	Day 30
Morphine Milligram Equivalents Use following Intervention	To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of SSRF without cryoablation.	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days in Hospital Stay	Hospital Length of Stay	Days during admission
Number of days in ICU Stay	ICU Length of Stay	Day 90
Amount of Chest tube drainage	Chest tube drainage	Day 90
Quality of Life Scores	Quality of Life questionnaire - Quality of life questionnaire consists of a set of survey questions that can be used to collect data related to an individual in particular and society in general on various parameters that determine their general quality of life	Month 1 and Month 3
Number of Mortalities in hospital	Mortality, in hospital	Day 90
Number of Readmissions	Readmission	30 day readmission rate
Number of Additional Thoracic Procedures	Additional Thoracic Procedures	Day 7

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Bradely W. Thomas, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: thoracotomy; Locoregional pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: IRB00084611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes